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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmJuly 19, 2005
Date PostedSeptember 01, 2005
Recall Status1 Terminated 3 on March 13, 2006
Recall NumberZ-1460-05
Recall Event ID 32801
510(K)NumberK042479 
Product Classification Enzyme Immunoassay, Gentamicin - Product Code LCD
ProductVITROS Chemistry GENT Reagent REF 680 1711, *** Responsible firm on label: Ortho-Clinical Diagnostics Inc., Rochester, NY 14626. Each box contains 6 packs. Each pack contains liquid reagent for 50 tests.
Code Information 01-5846, Exp. 31 May 2006; 01-6036 Exp 31 October 2006; 01-6239 Exp 31 January 2007
Recalling Firm/
Manufacturer		 Ortho-Clinical Diagnostics
100 Indigo Creek Dr
Rochester NY 14626-5101
For Additional Information ContactJudy M. Strzepek
908-218-8524
Manufacturer Reason
for Recall		Negatively biased results can be observed when the reagent pack has less than 12 tests remaining and has been on the analyzer greater than 24 hours.
FDA Determined
Cause 2		Other
ActionLetters dated 7/19/2005 with instructions to process QC fluid according to the IFU when processing patient samples. When replacement product arrives, instructions are to destroy the remaining inventory of the recalled lots.
Quantity in Commerce443 boxes
DistributionThe product was shipped nationwide and to Ortho-Clinical/J&J affiliates in Australia, Canada, Singapore, England, France, Germany, Italy and Spain.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = LCD
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